FDA.reportPublic FDA data

SHISEIDO ULTIMATE SUN PROTECTOR LOTION

Manufacturer
SHISEIDO AMERICAS CORPORATION | Shiseido America Inc.
Effective date
2025-03-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:57:30

Label at a glance#

ProductSHISEIDO ULTIMATE SUN PROTECTOR
Active ingredientOCTISALATE, HOMOSALATE, OCTOCRYLENE, AVOBENZONE
Label structure9 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every two hours Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: l...

Storage and handling

Protect this product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Octisalate 5.0%Sunscreen
Avobenzone 2.3%Sunscreen
Homosalate 10.0%Sunscreen
Octocrylene 5.0%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Flammable: Do not use near heat, flame, or while smoking.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every two hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

:WATER▪DIISOPROPYL SEBACATE▪TALC▪METHYL METHACRYLATE CROSSPOLYMER▪DIMETHICONE▪PEG/PPG-9/2 DIMETHYL ETHER▪SD ALCOHOL 40-B▪LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE▪TRIETHYLHEXANOIN▪GLYCERIN▪DEXTRIN PALMITATE▪SUCROSE TETRASTEARATE TRIACETATE▪ISODODECANE▪PPG-3 DIPIVALATE▪TRIMETHYLSILOXYSILICATE▪SILICA▪SODIUM CHLORIDE▪PEG/PPG-14/7 DIMETHYL ETHER▪SAXIFRAGA SARMENTOSA EXTRACT▪CAMELLIA SINENSIS LEAF EXTRACT▪SOPHORA ANGUSTIFOLIA ROOT EXTRACT▪PPG-17▪DISTEARDIMONIUM HECTORITE▪CALCIUM STEARATE▪ISOSTEARIC ACID▪PALMITIC ACID▪TRISODIUM EDTA▪ALCOHOL▪SILICA DIMETHYL SILYLATE▪VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER▪PEG-6▪BHT▪TOCOPHEROL▪BUTYLENE GLYCOL▪STEARIC ACID▪SODIUM METABISULFITE▪SYZYGIUM JAMBOS LEAF EXTRACT▪POLYSILICONE-2▪METHYLPARABEN▪FRAGRANCE▪IRON OXIDES▪

Other information

STORAGE AND HANDLING SECTION

Protect this product in this container from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 150 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO
GINZA TOKYO

Ultimate
Sun Protector Lotion

50+

SynchroShield
WetForce x HeatForce

Turns Invisible

BROAD SPECTRUM
SPF 50+

For Face/Body

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

150mL 5 FL. OZ.

Principal Display Panel - 150 mL Bottle Label
Principal Display Panel - 150 mL Bottle Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-481-10SHISEIDO ULTIMATE SUN PROTECTOR1 in 1 CARTONLOTION15
58411-481-10SHISEIDO ULTIMATE SUN PROTECTOR150 mL in 1 BOTTLELOTION1505
58411-481-11SHISEIDO ULTIMATE SUN PROTECTOR50 mL in 1 BOTTLELOTION505
58411-481-11SHISEIDO ULTIMATE SUN PROTECTOR1 in 1 CARTONLOTION15
58411-481-12SHISEIDO ULTIMATE SUN PROTECTOR1 in 1 CARTONLOTION15
58411-481-12SHISEIDO ULTIMATE SUN PROTECTOR300 mL in 1 BOTTLELOTION3005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-481SHISEIDO ULTIMATE SUN PROTECTOR (OCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONE) LOTION [SHISEIDO AMERICAS CORPORATION]5Current NDC, Legacy NDC, 6 package rows20250322_7a98171f-bf21-40d4-bc78-883aa0b0c438.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-48158411-481-10, 58411-481-11, 58411-481-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
TALC7SEV7J4R1UIACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
DIMETHICONE92RU3N3Y1OIACT
PEG/PPG-9/2 DIMETHYL ETHERLM6Q66468XIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
GLYCERINPDC6A3C0OXIACT
DEXTRIN PALMITATE (CORN; 20000 MW)89B2BSF9I3IACT
SUCROSE TETRASTEARATE TRIACETATE1K7LBQ045NIACT
ISODODECANEA8289P68Y2IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM CHLORIDE451W47IQ8XIACT
PEG/PPG-14/7 DIMETHYL ETHER6DNW9T7YT2IACT
SAXIFRAGA STOLONIFERA LEAFO3TMV4903HIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
PPG-17OV0Q322E0UIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
CALCIUM STEARATE776XM7047LIACT
ISOSTEARIC ACIDX33R8U0062IACT
PALMITIC ACID2V16EO95H1IACT
EDETATE TRISODIUM420IP921MBIACT
ALCOHOL3K9958V90MIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM METABISULFITE4VON5FNS3CIACT
SYZYGIUM JAMBOS LEAF407Z4W5LFFIACT
METHYLPARABENA2I8C7HI9TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONESHISEIDO AMERICAS CORPORATION7a98171f-bf21-40d4-bc78-883aa0b0c4382025-03-20WarningsExact identifier
ndc (package): 58411-481-12
ndc (package): 58411-481-11
ndc (package): 58411-481-10
ndc (product): 58411-481
ndc11 (package): 58411048112
ndc11 (package): 58411048111
ndc11 (package): 58411048110
spl id: e6522904-8d36-4733-bc3e-7eae181fc7a8
spl set id: 7a98171f-bf21-40d4-bc78-883aa0b0c438

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.